Mr. GREEN of Texas. Mr. Speaker, yesterday, the Institute of Medicine released its report on silicone breast implant research. It evaluated past studies on the association between silicone implants and diseases as well as considering the frequency of complications including rupture, the need for additional surgeries, and problems with contraction.

Perhaps the Institute of Medicine's most important directive was to recommend areas of future research concerning silicone breast implants.

The IOM, the Institute of Medicine, report points to the undeniable need for additional scientific research on the long-term outcomes and local complications of silicone breast implants. In fact, the report states these complications occur frequently enough to be a cause for concern and to justify the conclusion that they are the primary safety issue with silicone breast implants.

Although the rate of implant rupture and silicone leakage has not been definitively established, a recent analysis of implant failure conducted by the University of Florida found silicone breast implant rupture at a rate of 30 percent at 5 years, 50 percent at 10 years, and 70 percent at 17 years.

However, in information sent to women considering implants, manufacturers currently are grossly underestimating the rupture rate at 1 percent.

The Institute of Medicine, the IOM, also concluded that the information concerning the nature and relatively high frequency of local complications and reoperations is an essential element of adequate informed consent for women undergoing breast implantation.

Therefore, the IOM recommends the development of national model of informed consent of women undergoing breast implantation to ensure women fully understand the risks associated with silicone implants.

Women have the right to choose to get breast implants, but Congress has the responsibility to make sure that they are fully aware of the risks associated with these products.

For these reasons, I, along with the gentlewoman from New Mexico (Mrs. Wilson) and nearly 45 cosponsors have introduced H.R. 1323, the Silicone Breast Implant Research and Information Act.

This bill promotes independent research at NIH in order to ensure impartial, scientifically sound studies on silicone breast implants. To date, there have been no National Institutes of Health, NIH, clinical studies of mastectomy patients who have had implants.

With the level of attention and controversy on this issue, supporters of H.R. 1323 believe leadership from NIH is critically important.

Our legislation would also require the FDA to strengthen informed consent procedures in clinical trials and institute better follow-up mechanisms for consumer complaints. Because the FDA has never approved silicone breast implants for the market, it is crucial that women and their doctors have access to accurate information concerning the possible risks.

Finally, the Institute of Medicine, the IOM, recommends additional research to determine safe levels of silicone in the human body. Everyone has some level of silicone in their body. However, there has never been any research to establish a safe level of silicone. How can scientists be expected to determine whether silicone is causing diseases if we do not know what is the safe level?